Multi-parametric Imaging in Personalized Radiotherapy

Recruiting

• Conditions: Skull Base Chordoma
• Interventions: Diagnostic Test: diffusion MRI sequences

• Registration Number: NCT05888064
• Lead Sponsor: CNAO National Center of Oncological Hadrontherapy

Brief Summary

The study consists in the retrospective and prospective collection of imaging data (along with clinical information related to treatment) of skull-base chordoma patients treated with particle therapy, to derive imaging biomarkers which, integrated with advanced mathematical models, will allow predicting treatment outcome on a multi-scale basis.

Detailed Description

The study design consists of the retrospective collection of routinely-acquired data (CT, MRI and dose maps, along with relevant clinical information) and the prospective acquisition of optimized non-invasive MR imaging data, of skull-based chordoma patients treated with particle therapy (PT) at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).

This data will be stored in a proper repository under CNAO's control, shared with Politecnico di Milano through encrypted channels, and it will be used to implement mathematical models able to predict treatment outcome at different scales (macroscopic, microscopic and radiobiological).

Study Timeline

• Study Start: 2022-04-19
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-08-18
• Study Completion: 2025-08-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients with histologically confirmed diagnosis of chordoma of the skull base
• Particle therapy with curative intent
• Karnofsky Performance status greater than or equal to 60
• Patients with macroscopic disease detectable at pre-radiotherapy imaging
• Patients undergoing PT with standardized treatment procedures
• Patients who have signed the written informed consent for research

Exclusion Criteria

• Metastatic disease
• Palliative treatment
• Other malignancies with disease-free interval < 5 years (excepting pre- cancerous lesions)
• Pregnancy
• Simultaneous CHT or Immunotherapy
• Extensive metal instrumentation/implants
• Patients with autoimmune diseases (ADs) -including collagen-vascular (CVD) and inflammatory bowel (IBD)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective non-invasive MRI acquisitions are planned to be performed	diffusion MRI sequences	Prospective non-invasive MRI acquisitions are planned to be performed

Primary Outcome Measures

Name	Time	Method
collect data from MRI acquisition	1 year from the treatment provided in routine clinical setting	The prospective part of the study aims to collect data from MRI acquisition. It is not focused on patients treatment.

Trial Locations

Locations (1)

CNAO; 🇮🇹 Pavia, Pv, Italy